Analysis Shows No Reduction
In Approval Times
Had FDA Not Expanded Drug Evaluation Center

BETHESDA, MD—Prescription
drug review times have declined by 3.3 months for every 100 staff members added
to the Food and Drug Administration’s drug review division since 1977,
but the effects have been less pronounced since the federal government began
charging user fees to applicants in 1993, according to a new study published
on the Health Affairs Web site, www.healthaffairs.org.

The study authored by a group of scholars from the University of Michigan says
the reduction in approval times is more related to the resources appropriated
for the FDA than it is to the source of funding.

Before 1993, when the Prescription Drug User Fee Act (PDUFA) authorized the
FDA to begin collecting levies from pharmaceutical manufacturers and use them
to fund drug review activities, adding 100 staff members to the FDA sped approval
times by an average of 6.6 months, say the authors, led by Harvard University
government professor Daniel Carpenter, who did the work while he was at the
University of Michigan.

Their statistical analysis indicates that had staffing levels remained constant
following enactment of PDUFA, there would have been no reduction in approval
times.

“Our results do not uphold the industry’s claim that the recent
decline in approval times is entirely attributable to user fees,” Carpenter
says. “While PDUFA may have further reduced review times, it did so because
it increased staff resources at the FDA.

“We stress that a substantial staff-related decline occurred in the five
years before PDUFA’s passage,” Carpenter says. “We strongly
believe that nearly all of the decrease in approval times would have been achieved
had the FDA been appropriated these funds directly, instead of relying on user
fees.”

The authors also found:• Larger pharmaceutical
companies did not experience faster reviews
• Firms that spent more on lobbying did not experience faster reviews

Carpenter’s coauthors
were Michael Chernew, an associate economics professor in the University of
Michigan School of Public Health’s Department of Health Management and
Policy; Dean Smith, a health policy professor in the same department; and Mark
Fendrick, a professor of general medicine in the University of Michigan medical
school’s internal medicine department. Carpenter’s research is supported
by the National Science Foundation and the Robert Wood Johnson Foundation Scholars
in Health Policy Program.